Spinal Muscular AtrophyNCT07720518
Spinal Muscular Atrophy and School Transitions
An observational study of Spinal Muscular Atrophy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
A qualitative questionnaire-based study to explore the experiences of children and young people with Spinal Muscular Atrophy (SMA) and their families regarding school transition and educational participation. The study objectives: To identify barriers to successful educational transition. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Spinal Muscular Atrophy
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2026to 28 Feb 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants with a genetic diagnosis of Spinal Muscular Atrophy 1, 11 or 111.
Who may be able to join
- Genetically confirmed diagnosis of Spinal Muscular Atrophy 1, 11 or 111
- In education, in either primary school, secondary school or further education
- Access to internet and either a smart phone, tablet or computer.
Who cannot join
- Not in education
- Not able to comply with the consent process
- Not cognitively able to complete the questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
About this study
Official title: Exploring Educational Transitions in Children and Young People With Spinal Muscular Atrophy: A Qualitative Study of Patient and Family Experiences.
A qualitative questionnaire-based study to explore the experiences of children and young people with Spinal Muscular Atrophy (SMA) and their families regarding school transition and educational participation.
The study objectives:
To identify barriers to successful educational transition. To advocate for patients and families during the transitional process. To explore experiences of inclusion, access and support within school settings. To understand the coordination between education, healthcare and support services.
To inform the development of practical, patient-centred guidance to improve educational transitions for children and young people with SMA.
Read the detailed description
Neuromuscular diseases (NMDs) are a group of rare heterogeneous conditions which primarily affect the peripheral nervous system and skeletal muscle. Neuromuscular diseases are frequently progressive in nature and lead to increasing muscle weakness and systemic complications. Through advances in diagnosis and multidisciplinary clinical care there have been significant improvements in life expectancy and opportunities to have a fulling life. It is therefore imperative that transition, at all stages of a patient's journey, are supported and provide best opportunities.
It has been recognised for over 10 years that transition from paediatric to adult medical care has been fraught with issues and preparations for transition are often delayed until such time as the patient reaches or nears adult age or ignores completely. This has consequences for poorer outcomes in health and quality of life. Models do exist, but they lack depth and focus on the medical model, and so fault address all the criteria involved in a successful transition. Therefore, the period of transition from paediatric to adult healthcare is a time of uncertainty and stress for those with rare diseases. Both young adults and their parents/carers encounter a wide range of obstacles during the transition period, including poor understanding of the process, difficulty accessing appropriate support, expectations regarding future care and educational or work opportunities. During this transition period factors which exacerbate the stresses encountered are numerous, such as disease specific challenges and a lack of expertise amongst adult health care professionals, and wider care or education providers.
Transition is not merely an administrative process but a time that requires careful targeted multidisciplinary care to ensure that all the needs of a young person with NMDs are met. This not only should include medical transition but also psychological and social requirements. It is suggested that transition should start in young adolescence to prepare both patients and their families for changes in healthcare providers and introduce new teams and roles. Transition should be carefully planned with a patient family centred approach. Poor or inadequately planned transitions could cause negative outcomes related to prognosis of disease, mortality, psychosocial and educational attainment. Blum et al (1993) defines transition as 'the purposeful movement of adolescents with chronic physical and medical conditions from child-centred care to adult oriented healthcare systems'. However, Blum's definition is reductionist in nature and only addresses the health component; transition is better defined as 'the passage from one phase of a person's life, physical condition or social role to another'. And as such this could include transitions from ambulant to non-ambulant, requirement of overnight ventilation, sexual health and puberty, loss of social contacts, social inclusion, and all forms of transitions moving through the education system.
As is evident from the literature available on transition in those with NMD it is primarily focused on the medical transition. Most, if not all the literature suggests that transition starts in young adolescence and introduces the process of moving from paediatric healthcare to adult services.
The transition of those with NMDs when focused on healthcare does not address many areas of the transition that are important to ensure all opportunities are met. One unmet period of transition is that of moving from primary school to senior school, a time of great uncertainty and stress for both the patient and the parents/carers. The United Nations fourth sustainable global development goal is to ensure inclusive and equitable education and promote lifelong learning opportunities for all by 2030. However, those entering upper secondary education is at 86% for the non-disabled and only 66% for those with a disability or psychiatric diagnosis. In addition, those with NMDs are generally absent from school more often when compared to those without, the reasons being general poorer health, greater incidence of anxiety/depression, lack of learning opportunities, poor supportive infrastructure and insufficient compensatory education. It follows that to ensure all young persons with NMDs have access to education to better their quality of life and independence. The risk of not providing or having less than optimal access to education or absence due to appointments or ill health is a strong predictor of how well they will fair in life with regard to health, income, independence, employment, social inclusion and working life conditions.
The United Nations Convention on the Rights of Persons with Disabilities (CRPD) was adopted on 13th December 2006. There are 82 signatories to the Convention, 44 signatories to the Optional Protocol and 1 ratification of the protocol. The Convention has the goal of changing attitudes and approaches to people with disabilities. As part of the CRPS education was seen as an imperative and as such a whole section was devoted to this: Article 24 (see appendix 1 for full details). Article 24 of the CRPD lays out the basic and fundamental rights a disabled person has to a fair and non-discriminatory education with an emphasis on the States Parties to recognise and act so that all are given fair and equal opportunities.
The United Kingdom Government has a Disability Rights Act 2010. Included within that law is the right that protects the disabled from discrimination and provides legal rights including for education, free from direct or indirect discrimination, discrimination arising from disability, harassment, and victimisation. Schools have duty to provide 'reasonable adjustments' to ensure disable students are not discriminated against, however schools are 'not subject to the reasonable adjustment duty to make alterations to physical features, like adding ramps. They must make the buildings accessible for their disabled pupils as part of their overall planning duties'. Conversely, access to education for those with NMDs is not optimal and the transitions from primary school to and during the education journey are fraught with difficulties and barriers.
All NMDs should be approached as unique in their own right when considering transition and approached from a multidisciplinary perspective. The Spinal Muscular Atrophies (SMAs) are one such NMD that is a progressive neurodegenerative condition characterised by a significant and complex disease trajectory. The primary presentation is that of symmetrical proximal muscle weakness and atrophy, with associated loss of function. SMA presents with a broad spectrum of disease severity with classification based on age of onset and motor milestones achieved. SMA type I is the most common subtype, with approximately 42 babies being born each year in the United Kingdom with SMA type I, being symptomatic before age 6 months. Those affected do not achieve independent sitting, although prognosis is now much improved following the introduction of three disease modifying therapies. Those with type II SMA typically develop weakness between ages 6 to 18 months and can sit independently in early years. As the disease progresses the need for respiratory support and orthopaedic presentations, such as scoliosis and hip dysplasia, increase. SMA type III present with symptoms post 18 months and attain independent ambulation, however this may be lost as the disease progresses.
The CI is a member of the direct care team who treats this patient population. He would like to hold an initial focus group with 3 patients and their families to provide a consensus on the developing questionnaire, which will then be sent out to a further 9 patients and their families.
- Conditions
- Spinal Muscular Atrophy
- Keywords
- SMA type 11 and 111
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focus group | Discussion regarding the development of a questionnaire | |
| Completing questionnaire | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the questionnaire to explore the experiences of children and young people with SMA and their families regarding school transition and educational participation.
3 families will be invited to take place in a focus group discussion. Each family will be interviewed in a family unit on Microsoft Teams. These discussions will enable the development of a questionnaire which will be sent to 12 families to complete.
Measured: 1 month to complete the focus groups. 1 month to develop the questionnaire. 1 month to send questionnaires to 12 families and allow for the responses back.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start10 Aug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicholas Emery, Principal investigator, Neuromuscular Clinical Specialist Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720518
- Sponsor's protocol ID
- RL1 935
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Educational Transitions in Children and Young People With Spinal Muscular Atrophy: A Qualitative Study of Patient and Family Experiences.
- ClinicalTrials.gov ID
- NCT07720518
- Acronym / sponsor ID
- RL1 935
- Conditions
- Spinal Muscular Atrophy
- Keywords
- SMA type 11 and 111
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A qualitative questionnaire-based study to explore the experiences of children and young people with Spinal Muscular Atrophy (SMA) and their families regarding school transition and educational participation.
The study objectives:
To identify barriers to successful educational transition. To advocate for patients and families during the transitional process. To explore experiences of inclusion, access and support within school settings. To understand the coordination between education, healthcare and support services.
To inform the development of practical, patient-centred guidance to improve educational transitions for children and young people with SMA.
Detailed description
Neuromuscular diseases (NMDs) are a group of rare heterogeneous conditions which primarily affect the peripheral nervous system and skeletal muscle. Neuromuscular diseases are frequently progressive in nature and lead to increasing muscle weakness and systemic complications. Through advances in diagnosis and multidisciplinary clinical care there have been significant improvements in life expectancy and opportunities to have a fulling life. It is therefore imperative that transition, at all stages of a patient's journey, are supported and provide best opportunities.
It has been recognised for over 10 years that transition from paediatric to adult medical care has been fraught with issues and preparations for transition are often delayed until such time as the patient reaches or nears adult age or ignores completely. This has consequences for poorer outcomes in health and quality of life. Models do exist, but they lack depth and focus on the medical model, and so fault address all the criteria involved in a successful transition. Therefore, the period of transition from paediatric to adult healthcare is a time of uncertainty and stress for those with rare diseases. Both young adults and their parents/carers encounter a wide range of obstacles during the transition period, including poor understanding of the process, difficulty accessing appropriate support, expectations regarding future care and educational or work opportunities. During this transition period factors which exacerbate the stresses encountered are numerous, such as disease specific challenges and a lack of expertise amongst adult health care professionals, and wider care or education providers.
Transition is not merely an administrative process but a time that requires careful targeted multidisciplinary care to ensure that all the needs of a young person with NMDs are met. This not only should include medical transition but also psychological and social requirements. It is suggested that transition should start in young adolescence to prepare both patients and their families for changes in healthcare providers and introduce new teams and roles. Transition should be carefully planned with a patient family centred approach. Poor or inadequately planned transitions could cause negative outcomes related to prognosis of disease, mortality, psychosocial and educational attainment. Blum et al (1993) defines transition as 'the purposeful movement of adolescents with chronic physical and medical conditions from child-centred care to adult oriented healthcare systems'. However, Blum's definition is reductionist in nature and only addresses the health component; transition is better defined as 'the passage from one phase of a person's life, physical condition or social role to another'. And as such this could include transitions from ambulant to non-ambulant, requirement of overnight ventilation, sexual health and puberty, loss of social contacts, social inclusion, and all forms of transitions moving through the education system.
As is evident from the literature available on transition in those with NMD it is primarily focused on the medical transition. Most, if not all the literature suggests that transition starts in young adolescence and introduces the process of moving from paediatric healthcare to adult services.
The transition of those with NMDs when focused on healthcare does not address many areas of the transition that are important to ensure all opportunities are met. One unmet period of transition is that of moving from primary school to senior school, a time of great uncertainty and stress for both the patient and the parents/carers. The United Nations fourth sustainable global development goal is to ensure inclusive and equitable education and promote lifelong learning opportunities for all by 2030. However, those entering upper secondary education is at 86% for the non-disabled and only 66% for those with a disability or psychiatric diagnosis. In addition, those with NMDs are generally absent from school more often when compared to those without, the reasons being general poorer health, greater incidence of anxiety/depression, lack of learning opportunities, poor supportive infrastructure and insufficient compensatory education. It follows that to ensure all young persons with NMDs have access to education to better their quality of life and independence. The risk of not providing or having less than optimal access to education or absence due to appointments or ill health is a strong predictor of how well they will fair in life with regard to health, income, independence, employment, social inclusion and working life conditions.
The United Nations Convention on the Rights of Persons with Disabilities (CRPD) was adopted on 13th December 2006. There are 82 signatories to the Convention, 44 signatories to the Optional Protocol and 1 ratification of the protocol. The Convention has the goal of changing attitudes and approaches to people with disabilities. As part of the CRPS education was seen as an imperative and as such a whole section was devoted to this: Article 24 (see appendix 1 for full details). Article 24 of the CRPD lays out the basic and fundamental rights a disabled person has to a fair and non-discriminatory education with an emphasis on the States Parties to recognise and act so that all are given fair and equal opportunities.
The United Kingdom Government has a Disability Rights Act 2010. Included within that law is the right that protects the disabled from discrimination and provides legal rights including for education, free from direct or indirect discrimination, discrimination arising from disability, harassment, and victimisation. Schools have duty to provide 'reasonable adjustments' to ensure disable students are not discriminated against, however schools are 'not subject to the reasonable adjustment duty to make alterations to physical features, like adding ramps. They must make the buildings accessible for their disabled pupils as part of their overall planning duties'. Conversely, access to education for those with NMDs is not optimal and the transitions from primary school to and during the education journey are fraught with difficulties and barriers.
All NMDs should be approached as unique in their own right when considering transition and approached from a multidisciplinary perspective. The Spinal Muscular Atrophies (SMAs) are one such NMD that is a progressive neurodegenerative condition characterised by a significant and complex disease trajectory. The primary presentation is that of symmetrical proximal muscle weakness and atrophy, with associated loss of function. SMA presents with a broad spectrum of disease severity with classification based on age of onset and motor milestones achieved. SMA type I is the most common subtype, with approximately 42 babies being born each year in the United Kingdom with SMA type I, being symptomatic before age 6 months. Those affected do not achieve independent sitting, although prognosis is now much improved following the introduction of three disease modifying therapies. Those with type II SMA typically develop weakness between ages 6 to 18 months and can sit independently in early years. As the disease progresses the need for respiratory support and orthopaedic presentations, such as scoliosis and hip dysplasia, increase. SMA type III present with symptoms post 18 months and attain independent ambulation, however this may be lost as the disease progresses.
The CI is a member of the direct care team who treats this patient population. He would like to hold an initial focus group with 3 patients and their families to provide a consensus on the developing questionnaire, which will then be sent out to a further 9 patients and their families.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus group | – | –Discussion regarding the development of a questionnaire |
| Completing questionnaire | – | – |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants with a genetic diagnosis of Spinal Muscular Atrophy 1, 11 or 111.
Key inclusion criteria (3 listed)
- Genetically confirmed diagnosis of Spinal Muscular Atrophy 1, 11 or 111
- In education, in either primary school, secondary school or further education
- Access to internet and either a smart phone, tablet or computer.
Key exclusion criteria (3 listed)
- Not in education
- Not able to comply with the consent process
- Not cognitively able to complete the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of the questionnaire to explore the experiences of children and young people with SMA and their families regarding school transition and educational participation.
Time frame: 1 month to complete the focus groups. 1 month to develop the questionnaire. 1 month to send questionnaires to 12 families and allow for the responses back.
3 families will be invited to take place in a focus group discussion. Each family will be interviewed in a family unit on Microsoft Teams. These discussions will enable the development of a questionnaire which will be sent to 12 families to complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Emery principal investigator
Neuromuscular Clinical Specialist Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Muscular Atrophy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (01691 404418 ext. 4418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the questionnaire to explore the experiences of children and young people with SMA and their families regarding school transition and educational participation. (time frame: 1 month to complete the focus groups. 1 month to develop the questionnaire. 1 month to send questionnaires to 12 families and allow for the responses back.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.